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yogurt products in the United Kingdom (Entis, 2007). The conserve maker substituted aspartame for sugar without altering the rest of the formulation and without altering processing. The sugar present in the original formulation prevented the growth of Clostridium botulinum, but with its removal, this organism was able to grow and eventually led to the death of 1 person and serious illness in 25 others. This event is an example of the unfortunate outcomes that are possible if the safety-related functions of ingredients are not considered during reformulation. However, such events are preventable with adequate food safety expertise and product testing.

Consistent with FDA authorities and mission, the proposed changes to the status of GRAS substances must be demonstrated to be safe before they can be incorporated into regulation and implemented. To avoid problems from occurring during sodium reduction, food companies generally evaluate the potential for reduced sodium levels to increase food safety risks and engineer additional hurdles to microbial threats (as described in Chapter 4) into the product. In addition, it is generally standard practice to validate the safety of new and reformulated products using shelf life testing. The results of these tests will determine the limits of sodium reduction for specific food products and provide information that can be used to educate the standard setting process for acceptable conditions of use. Such testing, for example, may help to determine the potential for the growth of Listeria monocytogenes—an organism that has raised food safety concerns during UK efforts to reduce salt—in reduced-sodium deli meats or cheeses (Advisory Committee on the Microbiological Safety of Food ad hoc Group on Vulnerable Groups, 2008). Such testing is time consuming, requiring that adequate phase-in periods be provided to ensure that the push for a lower-sodium food supply does not result in unintended food safety problems. Smaller companies may not have as great a capacity to quickly undertake the studies needed to ensure the safety of reformulated foods and may need more time to meet sodium reduction goals than larger companies with significant resources for research and development. Specialized guidance from FDA, trade associations, and the Cooperative Extension service may also help to fill knowledge gaps in companies with limited research and development staffs. With sufficient guidance, standards for conditions of use that recognize food safety limitations, and the regular practice of validating product safety with shelf life testing, most food safety concerns should be avoidable.

Iodine Insufficiency

Until the 1920s, endemic iodine deficiency was a major public health problem in the Great Lakes, Appalachian, and Northwestern regions of the United States (Pearce, 2007). The introduction of iodized salt on a volun-

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